Tentative approval for bendamustine solution


The FDA grants tentative approval to Eagle Pharmaceuticals' (EGRX -0.5%) NDA for a ready-to-dilute concentrate version of bendamustine hydrochloride for the treatment of Indolent B-cell non-Hodgkin lymphoma. The product is currently marketed as a lyophilized powder requiring reconstitution and dilution.

The approval is termed "tentative" because of the company's ongoing patent litigation with (TEVA +2.1%) and the resolution or expiry of certain Orphan Drug exclusivities held by Teva.

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